Cervical Cancer
Conditions
Keywords
Colposcopy, Cervical cancer prevention, Adherence to follow-up, Unmet social needs, Distress
Brief summary
The investigators will perform a randomized controlled trial in which 72 eligible patients (low-income, uninsured, or on Medicaid) who are referred for colposcopy at Washington University School of Medicine, are enrolled and then screened for unmet social needs and distress. The participants will then be randomized 1:1 into either receive the social needs navigator program (n=36) or enhanced usual care (n=36).
Interventions
BEHAVIORALSocial needs navigator program
4 months of assistance tailored to the needs of the participant
BEHAVIORALEnhanced usual care
Referral to United Way 2-1-1
Sponsors
Washington University School of Medicine
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Abnormal cervical cancer screen * Missed appointment at BJH colposcopy clinic and need to reschedule * Age 21 years or older * Able to provide verbal consent * Diagnosis of an abnormal cervical screen confirmed by cytology or pathology
Exclusion criteria
* Individual without a cervix * Known diagnosis or history of cancer * Unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to Colposcopy Visit as Measured as Number of Participants Who Complete Colposcopy Visit Within 6 Weeks After Enrollment | From enrollment through 6 weeks after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Unmet Basic Needs | 4 months after enrollment | -Unmet basic needs include food security, housing, personal safety, neighborhood safety, sufficient money for necessities, childcare (if applicable), and transportation. A questionnaire will be given to participants to identify the number of unmet basic needs the participant has. |
| Change in General Distress Score as Measured by the NCCN Distress Thermometer and Problem List | Enrollment and 4 months after enrollment | Participants will be asked to rate the amount of distress (scale of 0 to 10, 10=extreme distress) that they have experienced in the past week and the amount of distress (scale of 0 to 10) that they attribute to their abnormal cervical cancer screen. The NCCN distress problem list is a 40-item list categorized into five themes-practical, family, emotional, spiritual, and physical problems¬-and leaves room for patients to describe "other". A higher score indicates the greater the amount of distress. |
| Intent to Use Intervention Over Time | Completion of study enrollment (estimated to be 18 months) | -Providers are asked after completion of enrollment to indicate on a scale of 1=not committed to 10=fully committed of how committed they are to use the intervention in their clinic. |
| Patients' Satisfaction With Intervention | Completion of study enrollment (estimated to be 18 months) | -The interview guide has two questions that relate to patient satisfaction related to the intervention. 1) Was the \[community health worker or 2-1-1 operator\] helpful to you? 2) Would you recommend \[the community healthworker/2-1-1\] to a family member or friend? |
| Providers' Satisfaction With Intervention | Completion of study enrollment (estimated to be 18 months) | -Providers are asked after completion of enrollment to indicate their satisfaction with the intervention. They are given 12 statements about the satisfaction of the intervention and are asked to circle responses of 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, or 5=completely agree. The higher the score the more satisfied the provider is with the intervention. |
| Resources Needed to Sustain Intervention | Completion of study enrollment (estimated to be 18 months) | -Validated questionnaire that will be administered to providers, staff, and community health workers: Self-administered 15-minute online survey that will be completed at the end of the study enrollment period. The survey will ask about specific implementation outcomes using the Acceptability Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure. |
| Likelihood That Intervention Will Become Built Into Usual Care | Completion of study enrollment (estimated to be 18 months) | -Providers are asked after completion of enrollment to indicate the likelihood that the intervention can be built into usual care in their clinic. The responses are either likely, very likely, neutral, unlikely, very unlikely, or unsure. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLindsay M Kuroki, M.D.
Washington University School of Medicine
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
None listed